Surgical instrument and method

ABSTRACT

A surgical instrument comprises a member connected with a spinal implant defining an axis. A first image guide is connected with the member and oriented relative to a sensor to communicate a signal representative of a position of the member. A second image guide is connected with the member and oriented to represent an angle measuring a second orientation of the axis relative to a first orientation. Systems, implants and methods are disclosed.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/480,153, filed on Apr. 5, 2017, which is hereby expresslyincorporated herein by reference, in its entirety.

TECHNICAL FIELD

The present disclosure generally relates to medical devices for thetreatment of musculoskeletal disorders, and more particularly to asurgical system and a method for treating a spine.

BACKGROUND

Spinal pathologies and disorders such as degenerative disc disease, discherniation, osteoporosis, spondylolisthesis, stenosis, scoliosis andother curvature abnormalities, kyphosis, tumor, and fracture may resultfrom factors including trauma, disease and degenerative conditionscaused by injury and aging. Spinal disorders typically result insymptoms including deformity, pain, nerve damage, and partial orcomplete loss of mobility.

Non-surgical treatments, such as medication, rehabilitation and exercisecan be effective, however, may fail to relieve the symptoms associatedwith these disorders. Surgical treatment of these spinal disordersincludes fusion, fixation, correction, corpectomy, discectomy,laminectomy and implantable prosthetics. For example, fusion andfixation treatments may be performed that employ implants to restore themechanical support function of vertebrae. Surgical instruments areemployed, for example, to prepare tissue surfaces for disposal of theimplants. Surgical instruments are also employed to engage implants fordisposal with the tissue surfaces at a surgical site. This disclosuredescribes an improvement over these prior technologies.

SUMMARY

In one embodiment, a surgical instrument is provided. The surgicalinstrument comprises a member connectable with a head of a bone fastenerhaving a shaft attachable with tissue. The member is movable with thehead to identify a range of movement of the head relative to the shaft.An image guide is connected with the member and oriented relative to asensor to communicate a signal representative of the range of movement.In some embodiments, surgical systems, implants, spinal constructs andmethods are provided.

In one embodiment, a method for treating a spine is provided. The methodcomprising the steps of: engaging a surgical instrument with a head ofat least one bone fastener having a shaft attached with tissue; andmoving the surgical instrument with the head to identify a range ofmovement of the head relative to the shaft, the surgical instrumentincluding an image guide oriented relative to a sensor to communicate asignal representative of the range of movement.

In one embodiment, a surgical system is provided. The surgical systemcomprises at least one bone fastener including a head and a shaftattachable with tissue. The head includes a selected movementconfiguration relative to the shaft. A surgical instrument isconnectable with the head and is movable with the head to identify arange of movement of the head relative to the shaft. The surgicalinstrument includes an image guide oriented relative to a sensor tocommunicate a signal representative of the range of movement. A trackingdevice includes the sensor that receives the signal and communicateswith a processor to generate data for display of an image from amonitor. The image represents position of the at least one bone fastenerrelative to the tissue.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure will become more readily apparent from thespecific description accompanied by the following drawings, in which:

FIG. 1 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 2 is a schematic representation of movement of components of thesystem shown in FIG. 1;

FIG. 3 is a schematic representation of movement of components of thesystem shown in FIG. 1;

FIG. 4 is a perspective view of components one embodiment of a surgicalsystem in accordance with the principles of the present disclosure; and

FIG. 5 is a perspective view of components one embodiment of a surgicalsystem in accordance with the principles of the present disclosuredisposed with vertebrae.

DETAILED DESCRIPTION

The exemplary embodiments of a surgical system are discussed in terms ofmedical devices for the treatment of musculoskeletal disorders and moreparticularly, in terms of a surgical system for preparing a surgicalsite, and a method for treating a spine. In some embodiments, thesurgical system includes a surgical instrument having an image guideoriented relative to a sensor to communicate a signal representative ofa range of movement of a receiver of a bone fastener. In someembodiments, the surgical system includes a surgical navigation systemand/or an automated rod bending device.

In some embodiments, the present surgical system includes a surgicalinstrument that identifies screw head impingement recognition withsurgical navigation, which can provide rod bending optimization. In someembodiments, the present surgical system is employed with a method forposterior fusion rod bending. In some embodiments, the present surgicalsystem is employed with a method such that a navigation systemidentifies individual screw head data points located in threedimensional space and a processor interpolates and displays an imagebetween these points to form a shape of a spinal rod. In someembodiments, the method includes identifying flexibility of one or morereceivers or tulip heads of bone fasteners. In some embodiments, theimplanted flexibility in the receivers is based on the design of thereceiver and the proximity of an outer boundary of the receiver to apatient's bony anatomy. For example, when the receiver contacts the bonyanatomy, the potential flexibility is reduced due to the impingement.

In some embodiments, the present surgical system includes a surgicalinstrument employed with a method of using a navigation system tomeasure the actual receiver angular displacement by allowing a surgeonto perform a circular sweeping motion of the navigated surgicalinstrument and recording the allowable displacement of the receiver perthe bony impingement points. For example, the identified true angularallowance can be used to optimize a rod bending software model andeliminate unnecessary contouring and/or weakening of fixation rods.

In some embodiments, the present surgical system includes a surgicalinstrument employed with a method used to measure the actual flexibilityof a screw head after insertion into a pedicle. In some embodiments, thepresent surgical system provides data signals that are then delivered toan automated rod bending device for optimized rod shaping. In someembodiments, the present surgical system provides actual flexibility ofeach screw head to optimize a fixation rod path between screws duringautomated rod bending. In some embodiments, the present surgical systemidentifies impingement of the screw on the bony anatomy to avoidrestriction on receiver flexibility.

In some embodiments, the present surgical system includes a surgicalinstrument that has an instrument tracker and a distal/working end. Insome embodiments, the surgical tracker provides indicia and/or displayof a location and angulation of the surgical instrument and itsdistal/working end. In some embodiments, the surgical system includes asurgical instrument having one or more image guides, which include oneor more fiducial markers. In some embodiments, the fiducial markerincludes a single ball-shaped marker. In some embodiments, the imageguide is disposed adjacent a proximal end of the surgical instrument. Insome embodiments, the image guide provides indicia and/or display of aprecise rotational and/or linear position of the image guide on thesurgical instrument. In some embodiments, this configuration providesindicia and/or display of an amount of manipulation, movement,translation and/or rotation of the implant with tissue.

In some embodiments, the surgical system includes a surgical instrumenthaving one or more image guides, which include a tracker that provideslocation of a surgical instrument in three dimensions, and a trackerthat provides location of the surgical instrument and/or a spinalimplant in two dimensions, such as, for example, a selected plane. Insome embodiments, this configuration provides indicia and/or display ofimplant position corresponding to an amount of manipulation, movement,translation and/or rotation of the implant with tissue.

In some embodiments, the surgical system comprises a navigationcompatible, surgical instrument that detects and/or identifies range ofmovement of a spinal implant disposed with tissue. In some embodiments,the surgical instrument includes a tracking and/or mapping tool thatidentifies range of motion limits due to tissue impingement. In someembodiments, the surgical instrument has one or more image guides, whichprovide position and rotation indicia and/or display of a spinal implantvia a camera sensor and a computer display screen. In some embodiments,the surgical system includes a surgical instrument that has two imageguide arrays.

In some embodiments, the surgical instrument includes a navigationtracker that is optically tracked and requires a line-of-sight view to asensor, such as, for example, a camera. In some embodiments, thesurgical system includes a navigation tracker attached to a surgicalinstrument and is disposed in a direct line of sight of a sensor, whichincludes one or more cameras. In some embodiments, the surgical systemincludes an O-arm medical imaging device that digitally captures imagesof an anatomy. In some embodiments, the tracker communicates with asurgical navigation system to determine and/or display surgicalinstrument positioning relative to the anatomy.

In some embodiments, one or all of the components of the surgical systemmay be disposable, peel pack and/or pre packed sterile devices. One orall of the components of the surgical system may be reusable. Thesurgical system may be configured as a kit with multiple sized andconfigured components.

In some embodiments, the surgical system of the present disclosure maybe employed to treat spinal disorders such as, for example, degenerativedisc disease, disc herniation, osteoporosis, spondylolisthesis,stenosis, scoliosis and other curvature abnormalities, kyphosis, tumorand fractures. In some embodiments, the surgical system of the presentdisclosure may be employed with other osteal and bone relatedapplications, including those associated with diagnostics andtherapeutics. In some embodiments, the surgical system may bealternatively employed in a surgical treatment with a patient in a proneor supine position, and/or employ various surgical approaches to thespine, including anterior, posterior, posterior mid-line, lateral,postero-lateral, and/or antero-lateral approaches, and in other bodyregions. The surgical system of the present disclosure may also bealternatively employed with procedures for treating the lumbar,cervical, thoracic, sacral and pelvic regions of a spinal column. Thesurgical system of the present disclosure may also be used on animals,bone models and other non-living substrates, such as, for example, intraining, testing and demonstration.

The surgical system of the present disclosure may be understood morereadily by reference to the following detailed description of theembodiments taken in connection with the accompanying drawing figures,which form a part of this disclosure. It is to be understood that thisapplication is not limited to the specific devices, methods, conditionsor parameters described and/or shown herein, and that the terminologyused herein is for the purpose of describing particular embodiments byway of example only and is not intended to be limiting. In someembodiments, as used in the specification and including the appendedclaims, the singular forms “a,” “an,” and “the” include the plural, andreference to a particular numerical value includes at least thatparticular value, unless the context clearly dictates otherwise. Rangesmay be expressed herein as from “about” or “approximately” oneparticular value and/or to “about” or “approximately” another particularvalue. When such a range is expressed, another embodiment includes fromthe one particular value and/or to the other particular value.Similarly, when values are expressed as approximations, by use of theantecedent “about,” it will be understood that the particular valueforms another embodiment. It is also understood that all spatialreferences, such as, for example, horizontal, vertical, top, upper,lower, bottom, left and right, are for illustrative purposes only andcan be varied within the scope of the disclosure. For example, thereferences “upper” and “lower” are relative and used only in the contextto the other, and are not necessarily “superior” and “inferior”.

As used in the specification and including the appended claims,“treating” or “treatment” of a disease or condition refers to performinga procedure that may include administering one or more drugs to apatient (human, normal or otherwise or other mammal), employingimplantable devices, and/or employing instruments that treat thedisease, such as, for example, microdiscectomy instruments used toremove portions bulging or herniated discs and/or bone spurs, in aneffort to alleviate signs or symptoms of the disease or condition.Alleviation can occur prior to signs or symptoms of the disease orcondition appearing, as well as after their appearance. Thus, treatingor treatment includes preventing or prevention of disease or undesirablecondition (e.g., preventing the disease from occurring in a patient, whomay be predisposed to the disease but has not yet been diagnosed ashaving it). In addition, treating or treatment does not require completealleviation of signs or symptoms, does not require a cure, andspecifically includes procedures that have only a marginal effect on thepatient. Treatment can include inhibiting the disease, e.g., arrestingits development, or relieving the disease, e.g., causing regression ofthe disease. For example, treatment can include reducing acute orchronic inflammation; alleviating pain and mitigating and inducingre-growth of new ligament, bone and other tissues; as an adjunct insurgery; and/or any repair procedure. As used in the specification andincluding the appended claims, the term “tissue” includes soft tissue,ligaments, tendons, cartilage and/or bone unless specifically referredto otherwise.

The following discussion includes a description of a surgical systemincluding a surgical instrument, related components and methods ofemploying the surgical system in accordance with the principles of thepresent disclosure. Alternate embodiments are disclosed. Reference ismade in detail to the exemplary embodiments of the present disclosure,which are illustrated in the accompanying figures. Turning to FIGS. 1and 2, there are illustrated components of a surgical system 10.

The components of surgical system 10 can be fabricated from biologicallyacceptable materials suitable for medical applications, includingmetals, synthetic polymers and/or ceramics. For example, the componentsof surgical system 10, individually or collectively, can be fabricatedfrom materials such as stainless steel alloys, aluminum, commerciallypure titanium, titanium alloys, Grade 5 titanium, super-elastic titaniumalloys, cobalt-chrome alloys, superelastic metallic alloys (e.g.,Nitinol, super elasto-plastic metals, such as GUM METAL®), ceramics,thermoplastics such as polyaryletherketone (PAEK) includingpolyetheretherketone (PEEK), polyetherketoneketone (PEKK) andpolyetherketone (PEK), carbon-PEEK composites, PEEK-BaSO₄ polymericrubbers, polyethylene terephthalate (PET), fabric, silicone,polyurethane, silicone-polyurethane copolymers, polymeric rubbers,polyolefin rubbers, hydrogels, semi-rigid and rigid materials,elastomers, rubbers, thermoplastic elastomers, thermoset elastomers,elastomeric composites, rigid polymers including polyphenylene,polyamide, polyimide, polyetherimide, polyethylene and/or epoxy,

Various components of surgical system 10 may have material composites,including the above materials, to achieve various desiredcharacteristics such as strength, rigidity, elasticity, compliance,biomechanical performance, durability and radiolucency or imagingpreference. The components of surgical system 10, individually orcollectively, may also be fabricated from a heterogeneous material suchas a combination of two or more of the above-described materials. Thecomponents of surgical system 10 may be monolithically formed,integrally connected or include fastening elements and/or instruments,as described herein.

Surgical system 10 is employed, for example, with a fully open surgicalprocedure, a minimally invasive procedure including percutaneoustechniques, and mini-open surgical techniques to customize and introduceinstrumentation and/or a spinal implant, such as, for example, one ormore bone fasteners at a surgical site of a patient, which includes, forexample, a spine having vertebrae V, as shown in FIG. 5.

Surgical system 10 includes a spinal implant, such as, for example, abone fastener 180. Bone fastener 180 comprises a screw shaft assembly 12and a head assembly 13. In some embodiments, screw shaft assembly 12 andhead assembly 13 are assembled in situ or prior to implant to form bonefastener 180, as described herein. Head assembly 13 includes a head,such as, for example, a receiver 14. Receiver 14 extends along anddefines an axis X1. Receiver 14 includes a pair of spaced apart arms 16,18 that define an implant cavity 20 therebetween configured for disposalof a component of a spinal construct, such as, for example, a spinal rod(not shown).

Arms 16, 18 each extend parallel to axis X1. In some embodiments, arm 16and/or arm 18 may be disposed at alternate orientations, relative toaxis X1, such as, for example, transverse, perpendicular and/or otherangular orientations such as acute or obtuse, coaxial and/or may beoffset or staggered. Arms 16, 18 each include an arcuate outer surfaceextending between a pair of side surfaces. At least one of the outersurfaces and the side surfaces of arms 16, 18 have at least one recessor cavity therein configured to receive an insertion tool, compressioninstrument and/or instruments for inserting and tensioning bone fastener180. In some embodiments, arms 16, 18 are connected at proximal anddistal ends thereof such that receiver 14 defines a closed spinal rodslot.

Cavity 20 is substantially U-shaped. In some embodiments, all or only aportion of cavity 20 may have alternate cross section configurations,such as, for example, closed, V-shaped, W-shaped, oval, oblongtriangular, square, polygonal, irregular, uniform, non-uniform, offset,staggered, and/or tapered. In some embodiments, receiver 14 includes aninner surface having a thread form located adjacent arm 16 and a threadform located adjacent arm 18. The thread forms are each configured forengagement with a coupling member, such as, for example, a setscrew (notshown), to retain the spinal rod within cavity 20. In some embodiments,receiver 14 may include alternate configurations, such as, for example,closed, open and/or side access.

Shaft assembly 12 extends along an axis X2 between a proximal portion 22and a distal tip 24. Shaft assembly 12 is configured for fixation withvertebrae, as described herein. Shaft assembly 12 includes a thread 26configured for engagement with vertebrae V, as shown in FIG. 1. Thread26 is continuous along a length of shaft assembly 12. In someembodiments, thread 26 may be intermittent, staggered, discontinuousand/or may include a single thread turn or a plurality of discretethreads. In some embodiments, other penetrating elements may be locatedon shaft assembly 12, such as, for example, a nail configuration, barbs,expanding elements, raised elements, ribs, and/or spikes to facilitateengagement of shaft 16 with tissue. In some embodiments, thread 26 maybe self-tapping or intermittent.

Receiver 14 includes a selected movement configuration with shaftassembly 12. In some embodiments, receiver 14 is rotatable and/orpivotable relative to shaft assembly 12 in a selected range of movementconfiguration, as described herein. The selected range of movement canbe limited due to engagement and/or impingement of receiver 14 withtissue. Such limitations of range of movement are identifiable and/ordetectable with a surgical instrument 25, as described herein. In someembodiments, bone fastener 180 is configured to selectively move betweenan orientation in which axis X1 extends parallel to axis X2 and iscoaxial with axis X2, and an orientation in which axis X1 extendstransverse to axis X2. In some embodiments, receiver 14 is connectablewith shaft assembly 12 to include a selected range of movementconfiguration such that bone fastener 180 comprises, for example, amulti-axial screw (MAS), a uni-axial screw (UAS), a sagittal adjustingscrew (SAS) or a transverse sagittal adjusting screw (TSAS). In someembodiments, surgical system 10 can include one or more multi-axialscrews, sagittal angulation screws, pedicle screws, mono-axial screws,uni-planar screws, facet screws, tissue penetrating screws, conventionalscrews, expanding screws and/or posts. In some embodiments, surgicalsystem 10 can include one or a plurality of bone fasteners, connectors,spinal rods and/or plates, which may be employed with a single vertebrallevel or a plurality of vertebral levels, and/or engaged with vertebraein various orientations, such as, for example, series, parallel, offset,staggered and/or alternate vertebral levels. In some embodiments,connection of receiver 14 with shaft assembly 12 can be actuated by amanual engagement and/or non-instrumented assembly, which may include apractitioner, surgeon and/or medical staff grasping receiver 14 andshaft assembly 12 and forcibly snap or pop fitting the componentstogether.

Receiver 14 is connectable with surgical instrument 25. Surgicalinstrument 25 includes a member 28 and is configured to identify a rangeof movement of receiver 14 relative to shaft assembly 12 and/or a rangeof movement of receiver 14 relative to tissue, as described herein.Member 28 includes a handle 38 and a shaft 40. Shaft 40 is configured toconnect member 28 with bone fastener 180, as described herein. Handle 38is configured to facilitate manipulating, moving, translating and/orrotating receiver 14 relative to shaft assembly 12 to identify and/ordetect range of movement data points, as described herein. Handle 38extends between an end 42 and an end 44 that extends from shaft 40, asshown in FIG. 1. In some embodiments, handle 38 may include alternatesurface configurations to enhance gripping of handle 38, such as, forexample, rough, arcuate, undulating, mesh, porous, semi-porous, dimpledand/or textured. In some embodiments, handle 38 may include alternatecross section configurations, such as, for example, oval, oblong,triangular, square, hexagonal, polygonal, irregular, uniform,non-uniform and/or tapered. In some embodiments, handle 38 may beassembled with shaft 40, as described herein. In some embodiments,handle 38 may be monolithically formed with shaft 40. In someembodiments, handle 38 may be disposed at alternate orientationsrelative to shaft 40, such as, for example, transverse, parallel,perpendicular and/or other angular orientations such as acute or obtuse,co-axial, offset, and/or staggered.

Shaft 40 is configured for connection with receiver 14 such that member28 can be fixed with receiver 14 to allow member 28 to move withreceiver 14. For example, as receiver 14 rotates or pivots relative toshaft assembly 12, member 28 rotates or pivots relative to shaftassembly 12. Receiver 14 and member 28 are configured to rotate aboutaxis X2 relative to shaft assembly 12, in the directions shown by arrowsA and B in FIG. 1, as provided by the selected movement configuration ofa bone fastener 180. In some embodiments, an outer surface of shaft 40is threaded and configured to mate with the thread forms of arms 16, 18to facilitate engagement of member 28 with receiver 14. A threadedengagement of member 28 with receiver 14, for example a clockwiserotation of shaft 40 relative to receiver 14, fixes receiver 14 withmember 28 such that shaft 40 is oriented to apply a force to receiver14. This force fixes a position of shaft 40 relative to receiver 14and/or forms a mating engagement between member 28 and bone fastener180. This configuration resists and/or prevents movement and/or rotationof member 28 relative to receiver 14.

To release member 28 from receiver 14, member 28 is disengaged fromreceiver 14, for example a counter-clockwise rotation of shaft 40relative to receiver 14, to release member 28 from receiver 14. In someembodiments, member 28 can be variously connected with receiver 14, suchas, for example, via an integral connection, friction fit, pressure fit,interlocking engagement, dovetail connection, clips, barbs, tongue ingroove, threaded, magnetic, key/keyslot and/or drill chuck.

Bone fastener 180, as described herein, includes receiver 14, which isconfigured for rotation relative to shaft assembly 12 in a selectedrange of movement configuration ROM1. In some embodiments, a selectedrange of movement configuration ROM1 of receiver 14 relative to shaftassembly 12 includes a MAS configuration. The MAS configuration ofreceiver 14 relative to shaft assembly 12 includes a selected range ofmovement configuration ROM1 having movement of receiver 14 in one or aplurality of axial orientations relative to shaft assembly 12. As such,receiver 14 is rotatable along a path x through an angle of 360 degreesabout axis X2 to define a perimeter and/or circumference correspondingto ROM1, as shown in FIG. 2, and includes relative rotation along theone or a plurality of axial orientations relative to shaft assembly 12.

In some embodiments, upon disposal of bone fastener 180 with tissue, theROM1 of receiver 14 relative to shaft assembly 12 can be limited and/orrestricted due to engagement and/or impingement of receiver 14 bypatient anatomy. For example, upon disposal of bone fastener 180 withtissue such that shaft assembly 12 penetrates tissue and an outersurface of receiver 14 is disposed adjacent the tissue, the actualflexibility and/or movement of receiver 14 relative to shaft assembly 12can be limited and/or impinged. Such engagement and/or impingement ofreceiver 14 limits and/or restricts the MAS configuration of ROM1 andthe actual movement of receiver 14 relative to shaft assembly 12includes a limited and/or restricted range of movement ROM2. As such,receiver 14 is rotatable along a path xx through an angle of 360 degreesabout axis X2 to define a limited and/or restricted perimeter and/orcircumference corresponding to ROM2, as shown in FIG. 3, and includes alimited and/or restricted rotation along the one or a plurality of axialorientations relative to shaft assembly 12. ROM2 includes a limitedand/or restricted range of movement of receiver 14 relative to shaftassembly 12 and/or tissue to which shaft assembly 12 is disposed that islimited due to impingement of receiver 14 by tissue. Path xx of receiver14 is determined at least in part by the location of bone or othertissue relative to an outer surface of receiver 14.

Member 28 tracks and/or maps the actual range of movement ROM2 when bonefastener 180 is implanted with tissue. In some embodiments, receiver 14is manipulated by member 28 in a selected motion, such as, for example,a sweeping rotational motion to identify and/or detect tissueimpingement of ROM1 to provide ROM2. In some embodiments, data pointsidentified and/or detected by surgical instrument 25 include range ofmovement ROM2, which are transmitted to a computer 220, which includesspinal rod bending software to determine a selected rod configurationand communicates commands to an automated rod bending device, asdescribed herein. In some embodiments, surgical instrument 25 identifiesand/or detects such data points to provide actual flexibility of eachreceiver 14 to optimize a fixation rod path between bone fasteners 180during automated rod bending, as described herein.

In some embodiments, surgical instrument 25 includes an image guide,such as, for example, a navigation component 30 connected with member28. Navigation component 30 is configured to generate a signalrepresentative of a position of receiver 14 and/or axis X1 relative toshaft assembly 12, axis X2 and/or tissue. In some embodiments, the imageguide may include human readable visual indicia, human readable tactileindicia, human readable audible indicia, one or more components havingmarkers for identification under x-ray, fluoroscopy, CT or other imagingtechniques, at least one light emitting diode, a wireless component, awired component, a near field communication component and/or one or morecomponents that generate acoustic signals, magnetic signals,electromagnetic signals and/or radiologic signals. In some embodiments,navigation component 30 is connected with member 28 via an integralconnection, friction fit, pressure fit, interlocking engagement, matingengagement, dovetail connection, clips, barbs, tongue in groove,threaded, magnetic, key/keyslot and/or drill chuck.

Navigation component 30 includes an emitter array 34. Emitter array 34is configured for generating a signal to a sensor array 202 of asurgical navigation system 200, as shown in FIG. 4 and described herein,representing the range of movement of receiver 14 relative to shaftassembly 12, for example ROM2, and/or a position or a trajectory ofreceiver 14 relative to shaft assembly 12 and/or tissue for display on amonitor 222.

In some embodiments, the signal generated by emitter array 34 representsproximity of an outer surface of receiver 14 relative to tissue, suchas, for example, bone. In some embodiments, the signal generated byemitter array 34 represents an actual range of movement of receiver 14relative to shaft assembly 12 and/or tissue. In some embodiments, thesignal generated by emitter array 34 represents a three dimensionalposition of bone fastener 180 relative to tissue. In some embodiments,the signal generated by emitter array 34 represents tissue impingementon receiver 14 that limits the range of movement of receiver 14 relativeto shaft assembly 12 and/or tissue. In some embodiments, the signalgenerated by emitter array 34 represents data points of bony impingementof receiver 14 with tissue.

In some embodiments, sensor array 202 receives signals from emitterarray 34 to provide a three-dimensional spatial position and/or atrajectory of receiver 14 and/or axis X1 relative to shaft assembly 12,axis X2 and/or tissue. Emitter array 34 communicates with a processor ofcomputer 220 of navigation system 200 to generate data for display of animage on monitor 222, as described herein. In some embodiments, sensorarray 202 receives signals from emitter array 34 to provide a visualrepresentation of range of movement ROM2 and/or an angular position ofreceiver 14 and/or axis X1 relative to shaft assembly 12, axis X2 and/ortissue. See, for example, similar surgical navigation components andtheir use as described in U.S. Pat. Nos. 6,021,343, 6,725,080,6,796,988, the entire contents of each of these references beingincorporated by reference herein.

Surgical navigation system 200 is configured for acquiring anddisplaying medical imaging, such as, for example, x-ray imagesappropriate for a given surgical procedure. In some embodiments,pre-acquired images of a patient are collected. In some embodiments,surgical navigation system 200 can include an O-arm® imaging device 204sold by Medtronic Navigation, Inc. having a place of business inLouisville, Colo., USA. Imaging device 204 may have a generally annulargantry housing that encloses an image capturing portion 208.

In some embodiments, navigation system 200 comprises an image capturingportion 208 that may include an x-ray source or emission portion and anx-ray receiving or image receiving portion located generally or aspractically possible 180 degrees from each other and mounted on a rotor(not shown) relative to a track of image capturing portion 208. Imagecapturing portion 208 can be operable to rotate 360 degrees during imageacquisition. Image capturing portion 208 may rotate around a centralpoint or axis, allowing image data of the patient to be acquired frommultiple directions or in multiple planes. Surgical navigation system200 can include those disclosed in U.S. Pat. Nos. 8,842,893, 7,188,998;7,108,421; 7,106,825; 7,001,045; and 6,940,941; the entire contents ofeach of these references being incorporated by reference herein.

In some embodiments, surgical navigation system 200 can include C-armfluoroscopic imaging systems, which can generate three-dimensional viewsof a patient. The position of image capturing portion 208 can beprecisely known relative to any other portion of an imaging device 204of navigation system 200. In some embodiments, a precise knowledge ofthe position of image capturing portion 208 can be used in conjunctionwith a tracking system 210 to determine the position of image capturingportion 208 and the image data relative to the patient.

Tracking system 210 can include various portions that are associated orincluded with surgical navigation system 200. In some embodiments,tracking system 210 can also include a plurality of types of trackingsystems, such as, for example, an optical tracking system that includesan optical localizer, such as, for example, sensor array 202 and/or anEM tracking system that can include an EM localizer. Various trackingdevices can be tracked with tracking system 210 and the information canbe used by surgical navigation system 200 to allow for a display of aposition of an item, such as, for example, a patient tracking device, animaging device tracking device 216, and an instrument tracking device,such as, for example, emitter array 34, to allow selected portions to betracked relative to one another with the appropriate tracking system.

In some embodiments, the EM tracking system can include theSTEALTHSTATION® AXIEM® Navigation System, sold by Medtronic Navigation,Inc. having a place of business in Louisville, Colo. Exemplary trackingsystems are also disclosed in U.S. Pat. Nos. 8,057,407, 5,913,820,5,592,939, the entire contents of each of these references beingincorporated by reference herein.

Fluoroscopic images taken are transmitted to a computer 218 where theymay be forwarded to computer 220. Image transfer may be performed over astandard video connection or a digital link including wired andwireless. Computer 220 provides the ability to display, via monitor 222,as well as save, digitally manipulate, or print a hard copy of thereceived images. In some embodiments, images may also be displayed tothe surgeon through a heads-up display.

In some embodiments, surgical navigation system 200 provides forreal-time tracking of bone fastener 180 such that ROM1, ROM2, theposition of receiver 14 relative to shaft assembly 12 and/or tissue canbe tracked. In some embodiments, real-time tracking of the position ofreceiver 14 relative to shaft assembly 12 and/or tissue can be limiteddue to impingement of receiver 14 with tissue, wherein such limitationsof range of movement, for example ROM2 are identifiable and/ordetectable with surgical instrument 25, as described herein. Sensorarray 202 is located in such a manner to provide a clear line of sightwith emitter array 34, as described herein. In some embodiments,fiducial markers 32 of emitter array 34 communicate with sensor array202 via infrared technology. Sensor array 202 is coupled to computer220, which may be programmed with software modules that analyze signalstransmitted by sensor array 202 to determine the position of each objectin a detector space.

In some embodiments, sensor array 202 communicates with computer 220 totransmit range of movement data of receiver 14 relative to shaftassembly 12, as described herein. In some embodiments, the processorsends such information to monitor 222, which provides a visualrepresentation of the range of movement of receiver 14 relative to shaftassembly 12. For example, range of movement ROM2 of receiver 14 relativeto shaft assembly 12 may affect the contouring of a spinal rod that isconfigured to be positioned within implant cavities 20 of bone fasteners180 to correct a spinal deformity. In some embodiments, the spinalcorrection and/or rod bending software can be employed to determine theshape of the spinal rod, based at least in part upon the range ofmovement of receiver 14 relative to shaft assembly 12, as describedherein, such that surgical instrument 25 identifies and/or detects ROM2data points to provide actual flexibility of each receiver 14 tooptimize a fixation rod path between bone fasteners 180 during automatedrod bending, as described herein. In some embodiments, the software isutilized to determine a selected spinal correction and the correspondingshape and/or contour of the spinal rod to fit within implant cavities 20of bone fasteners 180 by rotating receivers 14 relative to shaftassembly 12 within range of movement ROM2, as described herein.

In assembly, operation and use, surgical system 10, similar to thesystems and methods described herein, is employed with a surgicalprocedure for treatment of a spinal disorder affecting a section of aspine of a patient, as discussed herein. For example, the components ofsurgical system 10 can be used with a surgical procedure for treatmentof a condition or injury of an affected section of the spine includingvertebrae V, as shown in FIG. 5. In some embodiments, one or all of thecomponents of surgical system 10 can be delivered or implanted as apre-assembled device or can be assembled in situ. Surgical system 10 maybe completely or partially revised, removed or replaced.

The components of surgical system 10 can be employed with a surgicaltreatment of an applicable condition or injury of an affected section ofa spinal column and adjacent areas within a body, such as, for example,vertebrae V. In some embodiments, the components of surgical system 10may be employed with one or a plurality of vertebra. To treat a selectedsection of vertebrae V, a medical practitioner obtains access to asurgical site including vertebrae V in any appropriate manner, such asthrough incision and retraction of tissues. In some embodiments, thecomponents of surgical system 10 can be used in any existing surgicalmethod or technique including open surgery, mini-open surgery, minimallyinvasive surgery and percutaneous surgical implantation, wherebyvertebrae V are accessed through a mini-incision, or sleeve thatprovides a protected passageway to the area. Once access to the surgicalsite is obtained, the particular surgical procedure can be performed fortreating the spine disorder.

An incision is made in the body of a patient and a cutting instrument(not shown) creates a surgical pathway for delivery of components ofsurgical system 10 including bone fasteners 180, as described herein,adjacent an area within the patient's body, such as, for example,vertebrae V. In some embodiments, a preparation instrument (not shown)can be employed to prepare tissue surfaces of vertebrae V, as well asfor aspiration and irrigation of a surgical region.

Pilot holes are made in vertebrae V in a selected orientation. Bonefasteners 180 are each engaged with a driver. Each receiver 14 of thebone fasteners 180 to be attached with the tissue of vertebrae Vincludes a selected range of movement configuration ROM1. For example,an MAS bone fastener 180 includes a receiver 14 having a ROM1 relativeto shaft assembly 12, as shown in FIG. 2, and is rotatable along path xthrough an angle of 360 degrees about axis X2 to define a perimeterand/or circumference corresponding to ROM1. Bone fasteners 180 are eachaligned with one of the pilot holes and the drivers are rotated,torqued, inserted or otherwise connected with bone fasteners 180 suchthat bone fasteners 180 each translate axially within one of the pilotholes for engagement and fixation with the tissue of vertebrae V. Insome embodiments, at least one of bone fasteners 180 includes a MAS or aSAS movement configuration.

Surgical instrument 25 is connected with each bone fastener 180 toidentify a range of movement of receiver 14 relative to shaft assembly12 and/or a range of movement of receiver 14 relative to tissue, asdescribed herein. Shaft 40 is connected with each receiver 14 such thatmember 28 can be fixed with receiver 14 to allow member 28 to move withreceiver 14. As receiver 14 rotates or pivots relative to shaft assembly12, member 28 rotates or pivots relative to shaft assembly 12.

Member 28 is engaged with the receiver 14 of each bone fastener 180disposed with vertebrae V to track and/or map the actual range ofmovement ROM2 of each receiver 14 of the bone fasteners 180 implantedwith vertebrae V. Bone fasteners 180 are disposed with vertebrae V suchthat an outer surface of receiver 14 is disposed adjacent bone and theactual flexibility and/or movement of receiver 14 relative to shaftassembly 12 can be limited and/or impinged. Such engagement and/orimpingement of receiver 14 with tissue limits and/or restricts the ROM1of bone fastener 180 and the actual movement of receiver 14 relative toshaft assembly 12 includes a limited and/or restricted range of movementROM2. As such, receiver 14 is rotatable along a path xx through an angleof 360 degrees about axis X2 to define a limited and/or restrictedperimeter and/or circumference corresponding to ROM2, as shown in FIG.3, and includes a limited and/or restricted rotation along the one or aplurality of axial orientations relative to shaft assembly 12. Eachreceiver 14 is manipulated with member 28 in a sweeping rotationalmotion to identify and/or detect tissue impingement of ROM1 to provideROM2 such that surgical instrument 25 identifies and/or detects ROM2data points to provide actual flexibility of each receiver 14 tooptimize a fixation rod path between bone fasteners 180 during automatedrod bending, as described herein. Data points identified and/or detectedby surgical instrument 25 include range of movement ROM2, which aretransmitted to computer 220, which includes spinal rod bending softwareto determine a selected rod configuration and communicates commands toan automated rod bending device, as described herein. In someembodiments, surgical instrument 25 is employed to identify and/ordetect ROM2 data points of alternate movement configurations of a bonefastener, as described herein, for transmission to computer 220.

Sensor array 202 receives signals from emitter array 34 to provide athree-dimensional spatial position and/or a trajectory of receiver 14,as described herein. Emitter array 34 communicates with the processor ofcomputer 220 of navigation system 200 to generate ROM2 data points fordisplay from monitor 222. In some embodiments, this procedure isrepeated for each of bone fasteners 180.

The identified and/or mapped range of movement ROM2 includes data pointsthat are employed with a selected rod contour, spinal rod templateconfiguration and/or selected spinal correction treatment to calculate aselected spinal rod configuration for disposal with one or more of bonefasteners 180. The data points are communicated to the software ofcomputer 220, as described herein, and based on such data points,computer 220 generates three dimensional coordinates of the shape of aspinal rod 300 to be implanted with vertebrae V. Computer 220communicates a corresponding signal and/or commands to an automatedimplant bending device, which may be disposed within a sterile field, tocontour spinal rod 300. See, for example, the disclosure of automatedimplant bending devices, systems and methods shown and described incommonly owned and assigned U.S. patent application Ser. No. 15/479,051filed Apr. 4, 2017; the disclosure of automated implant bending devices,systems and methods shown and described in commonly owned and assignedU.S. patent application Ser. No. 15/479,585 filed Apr. 5, 2017; thedisclosure of automated implant bending devices, systems and methodsshown and described in commonly owned and assigned U.S. patentapplication Ser. No. 15/480,002 filed Apr. 5, 2017; and the disclosureof automated implant bending devices, systems and methods shown anddescribed in commonly owned and assigned U.S. patent application Ser.No. 15/480,123 filed Apr. 5, 2017, the entire contents of each of thesedisclosures being incorporated herein by reference.

In some embodiments, computer 220 generates three dimensionalcoordinates of the shape of spinal rod 300, which may be determined fromintra-operative fluoroscopy with bone fasteners 180 installed. In someembodiments, fluoroscopic images taken are transmitted to computer 220.Image transfer may be performed over a standard video connection or adigital link including wired and wireless. Computer 220 and/or thegraphical interface, as described herein, provides the ability todisplay, via monitor 222, as well as save, digitally manipulate, orprint a hard copy of the received images. In some embodiments, imagesmay also be displayed to the surgeon through a heads-up display.

In some embodiments, a graphical interface including monitor 222, asdescribed herein, provides three dimensional graphical representation ofspinal rod 300 formation. In some embodiments, the implant bendingdevice (not shown) communicates with computer 220 and/or the graphicalinterface to provide the curvature coordinates of spinal rod 300, whichmay include a geometric angle between two consecutive points on spinalrod 300. In some embodiments, the software of computer 220 determineshow to manipulate each of receivers 14 relative to shaft assemblies 12within selected range of movement configuration ROM2 such that spinalrod 300 can be positioned within implant cavities 20 to correct and/ortreat a condition or injury of vertebrae V.

In some embodiments, surgical system 10 includes an agent, which may bedisposed, packed or layered within, on or about the components and/orsurfaces of surgical system 10. In some embodiments, the agent mayinclude bone growth promoting material, such as, for example, bone graftto enhance fixation with vertebrae V. The components of surgical system10 can be made of radiolucent materials such as polymers. Radiomarkersmay be included for identification under x-ray, fluoroscopy, CT or otherimaging techniques. In some embodiments, the agent may include one or aplurality of therapeutic agents and/or pharmacological agents forrelease, including sustained release, to treat, for example, pain,inflammation and degeneration. Upon completion of the procedure, thesurgical instruments, assemblies and non-implanted components ofsurgical system 10 are removed from the surgical site and the incisionis closed.

It will be understood that various modifications may be made to theembodiments disclosed herein. Therefore, the above description shouldnot be construed as limiting, but merely as exemplification of thevarious embodiments. Those skilled in the art will envision othermodifications within the scope and spirit of the claims appended hereto.

What is claimed is:
 1. A method for treating a spine, the methodcomprising the steps of: moving a receiver of a bone fastener relativeto a shaft assembly of the bone fastener to define a perimetercorresponding to a first range of movement of the receiver relative tothe shaft assembly; implanting the shaft assembly with tissue; movingthe receiver relative to the shaft assembly to define a perimetercorresponding to a second range of movement of the receiver relative tothe shaft assembly; communicating a signal representative of the secondrange of movement from the surgical instrument to a computer; anddetermining a selected rod configuration based on the signal.
 2. Themethod recited in claim 1, further comprising: communicating commandsfrom the computer to an automated rod bending device; and bending a rodto have the selected rod configuration using the automated rod bendingdevice.
 3. The method recited in claim 1, wherein the step of moving thereceiver to define the perimeter corresponding to the second range ofmovement occurs after the step of implanting the shaft assembly.
 4. Themethod recited in claim 1, further comprising engaging a surgicalinstrument with the receiver before the step of moving the receiver todefine the perimeter corresponding to the second range of movement,wherein the surgical instrument includes an image guide orientedrelative to a sensor to communicate the signal representative of thesecond range of movement.
 5. The method recited in claim 1, furthercomprising engaging a surgical instrument with the receiver before thestep of moving the receiver to define the perimeter corresponding to thesecond range of movement, wherein the surgical instrument includes ashank defining a longitudinal axis and an image guide connected with theshank by a handle that is coaxial with the longitudinal axis.
 6. Themethod recited in claim 5, wherein the image guide comprises a pluralityof spaced apart emitters each extending from a surface of the imageguide that extends transverse to the longitudinal axis such that theemitters are positioned radially about the longitudinal axis.
 7. Themethod recited in claim 6, wherein the emitters are oriented relative toa sensor to communicate the signal representative of the second range ofmovement.
 8. The method recited in claim 1, further comprising engaginga surgical instrument with the receiver before the step of moving thereceiver to define the perimeter corresponding to the second range ofmovement, wherein the step of engaging the surgical instrument with thereceiver comprises mating a threaded outer surface of a shank of thesurgical instrument with thread forms of arms of the receiver such thatthe shank extends parallel to the arms.
 9. The method recited in claim1, wherein the signal represents a three dimensional position of thebone fastener relative to tissue.
 10. A method for treating a spine, themethod comprising the steps of: moving a receiver of a bone fastenerrelative to a shaft assembly of the bone fastener to define a perimetercorresponding to a first range of movement of the receiver relative tothe shaft assembly; implanting the shaft assembly with tissue; engaginga surgical instrument with the receiver; moving the surgical instrumentand the receiver relative to the shaft assembly to define a perimetercorresponding to a second range of movement of the receiver relative tothe shaft assembly; communicating a signal representative of the secondrange of movement from the surgical instrument to a computer; anddetermining a selected rod configuration based on the signal.
 11. Themethod recited in claim 10, wherein the second range of movement isdifferent than the first range of movement.
 12. The method recited inclaim 10, wherein the second range of movement is restricted relative tothe first range of movement.
 13. The method recited in claim 10, whereinthe second range of movement is limited relative to the first range ofmovement due to impingement of the receiver with patient anatomy. 14.The method recited in claim 10, further comprising: communicatingcommands from the computer to an automated rod bending device; andbending a rod to have the selected rod configuration using the automatedrod bending device.
 15. The method recited in claim 10, wherein: thestep of moving the receiver relative to the shaft assembly to define theperimeter corresponding to the first range of movement occurs before thestep of implanting the shaft assembly; and the step of moving thesurgical instrument and the receiver relative to the shaft assembly todefine the perimeter corresponding to the second range of movementoccurs after the step of implanting the shaft assembly.
 16. The methodrecited in claim 10, wherein the surgical instrument includes a shankdefining a longitudinal axis and an image guide connected with the shankby a handle that is coaxial with the longitudinal axis.
 17. The methodrecited in claim 16, wherein the image guide comprises a plurality ofspaced apart emitters each extending from a surface of the image guidethat extends transverse to the longitudinal axis such that the emittersare positioned radially about the longitudinal axis.
 18. The methodrecited in claim 17, wherein the emitters are oriented relative to asensor to communicate the signal representative of the second range ofmovement.
 19. The method recited in claim 10, wherein the signalrepresents a three dimensional position of the bone fastener relative totissue.
 20. A method for treating a spine, the method comprising thesteps of: moving a receiver of a bone fastener relative to a shaftassembly of the bone fastener to define a perimeter corresponding to afirst range of movement of the receiver relative to the shaft assembly;implanting the shaft assembly with tissue; engaging a surgicalinstrument with the receiver, the surgical instrument including a shankdefining a longitudinal axis and an image guide connected with the shankby a handle that is coaxial with the longitudinal axis, the image guidecomprising a plurality of spaced apart emitters each extending from asurface of the image guide that extends transverse to the longitudinalaxis such that the emitters are positioned radially about thelongitudinal axis; moving the surgical instrument and the receiverrelative to the shaft assembly to define a perimeter corresponding to asecond range of movement of the receiver relative to the shaft assembly,the second range of movement being different than the first range ofmovement; communicating a signal representative of the second range ofmovement from the image guide to a computer, the signal representing athree dimensional position of the bone fastener relative to tissue;determining a selected rod configuration based on the signal;communicating commands from the computer to an automated rod bendingdevice; and bending a rod to have the selected rod configuration usingthe automated rod bending device.